BEUDAMED
    FDA Recall Terminated

    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

    Recall: Z-0354-2020 · Initiated October 1, 2019

    Recall

    Recall Number
    Z-0354-2020
    Event Number
    83926
    Firm
    Monarch Medical Technologies
    FEI Number
    3009864844
    Product Code
    NDC
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    October 1, 2019
    Terminated
    February 10, 2026
    Address
    2137 South Blvd, Ste 300, Charlotte, NC, 28203-5189

    Description

    EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

    Reason

    Product was distributed prior to approval or clearance from FDA.

    Action

    The firm held meetings and emailed the consignees beginning on 09/27/2019 and followed with a letter. The notice stated that no medical decision should be based solely on the recommended guidance provided by the software program and requested the facility take additional precautions when following EndoTool SubQ dose recommendations.

    Distribution

    SC, IL IN, CA

    Quantity

    6 units